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REG - Immupharma PLC - Final Results

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RNS Number : 0214Z  Immupharma PLC  11 May 2023

RNS:
RELEASE

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

FINAL RESULTS ANNOUNCEMENT

for the year ended 31 December 2022

 

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug
discovery and development company, is pleased to announce its final results
for the twelve months ended 31 December 2022 (the "Period").

 

Key Highlights (including post Period review)

 

Financial

 

·    Loss for the Period of £3.8m (2021: £8.2m)

·    Research and development expenses of £2.0m (2021: £3.7m)

·    Administrative expenses of £0.8m (2021: £1.0m)

·    Exceptional items of £nil (2021: £1.4m, representing corporate
reorganisation costs)

·    Cash balance at 31 December 2022 of £0.7m (31 December 2021:
 £1.6m)

·    Successful subscription and placing, raising in total £2.0m (gross)
- August 2022

·    Lanstead derivative financial asset of £0.3m (2021: £0.9m)

·    Incanthera financial asset of £0.7m (2021: £1.2m)

·    Warrants financial asset of £0.001 (2021: £0.2m)

 

Product Development

 

·    P140 Pharmokinetic ("PK") study successfully completed in April 2022
with key findings shared with the FDA*

·    In February 2023 an adaptive Phase 2/3 study for Lupuzor™ in
SLE/Lupus patients was agreed with US partner, Avion Pharmaceuticals,
following guidance from the FDA

·    Type C meeting confirmed with FDA for 7 June 2023 for consideration
of the new protocol of the Phase 2/3 adaptive study for Lupuzor™ in SLE
patients

·    Pre-IND meeting confirmed with FDA for 16 May 2023 for feedback on
the new protocol of the Phase 2/3 adaptive study for CIDP

·    Collaboration with Orano - ImmuPharma peptide technology as a vector
for cancer radiotherapy - an initial collaboration for 12 months

 

*FDA (Food and Drug Administration)

 

Commenting on the statement and outlook Tim McCarthy, CEO, said:

"As a Board, we remain focused on bringing our two key late stage clinical
assets, Lupuzor™ for lupus and CIDP closer to the market. We now have a
clinical roadmap for Lupuzor™ and remain on track to commence the Phase 2/3
adaptive trial in H2 2023, with potentially CIDP moving into clinical studies
in parallel. This illustrates the potential franchise we have within our P140
autoimmune platform.

We will also continue to concentrate on further commercial and partnering
opportunities. In conjunction with the above objectives, we continue to take
prudent measures on managing our cost base.

In closing, we would like to thank our shareholders for their support as well
as our staff, corporate and scientific advisers and our partners including
CNRS and Avion."

Market Abuse Regulation (MAR) Disclosure

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK
VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH
LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED.  ON
PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS
INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 For further information please contact:

ImmuPharma PLC (www.immupharma.com (http://www.immupharma.com) )  + 44 (0) 2072 062650

 Tim McCarthy, Chief Executive Officer
 Dr Tim Franklin, Chief Operating Officer
 Lisa Baderoon, Head of Investor Relations                         + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                           +44 (0) 203 368 3550

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                          +44 (0) 203 650 3650

 Patrick Claridge, John Howes

 SI Capital (Joint Broker)                                         +44 (0) 1483 413500

 Nick Emerson

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ImmuPharma plc

 

Chairman's Report

 

2022 was a year of further transition for ImmuPharma as we continued to focus
on progressing our late-stage pipeline assets as well as dealing with some
complex regulatory processes, in conjunction with our partner Avion
Pharmaceuticals ("Avion") and in discussions with the US Food and Drug
Administration ("FDA").

 

In 2022, ImmuPharma continued its primary focus on progressing our late-stage
program, Lupuzor™ (P140), in conjunction with our US partner, Avion. During
the second half of 2021, ImmuPharma started preparations  for the
commencement of a clinical pharmacokinetic ("PK") study, as guided by the US
Food and Drug Administration ("FDA"). The PK study was successfully completed
in April 2022 with guidance from the FDA in respect to progressing Lupuzor's
clinical program,  announced in early 2023.  This confirmed that in
conjunction with Avion, we have agreed that the optimum route forward for
Lupuzor™ is for a dose ranging Phase 2/3 adaptive study. Our current target
is to commence this trial in H2 2023.

 

The PK study findings also contributed to progressing an additional autoimmune
clinical program for a new disease indication, CIDP (Chronic Idiopathic
Demyelinating Polyneuropathy).

 

In June 2022, our share capital structure was reorganised and in August 2022,
we concluded a successful fundraising of £2.04m (gross). ImmuPharma continued
to explore opportunities with other potential commercial partners ex-US for
P140 in lupus. Global partnerships are also being sought for  P140 in CIDP
and anti-infective assets from the Company's R&D pipeline.

 

Lupuzor™/P140 - opportunity and next steps

 

There are an estimated five million people suffering from lupus, with
approximately 5 million patients in the US, Europe and Japan (Source: Lupus
Foundation of America). The prevalence in China may be 2-3 times that seen in
the US. Current 'standard of care' treatments, including steroids and
immunosuppressants, can potentially have either serious side effects for
patients or limited efficacy, with over 60 per cent of patients not adequately
treated.

 

ImmuPharma believes Lupuzor™/P140 has the potential to be a novel specific
drug therapy for the treatment of Lupus by specifically modulating the immune
system and halting disease progression in most lupus patients. It has a unique
mechanism of action and is not an immunosuppressant like other drugs.
Lupuzor™/P140 normalises the over-activity of T-cells which are involved in
the immune response leading to lupus disease. Lupuzor™ taken over the long
term may have the potential to prevent the progression of lupus rather than
just treating its symptoms, with the rest of the immune system retaining the
ability to work normally.

 

A new major opportunity for P140 is CIDP, a rare acquired autoimmune disorder
of peripheral nerves. It is a neurological disorder characterized by
progressive weakness and impaired sensory function in the legs and arms. CIDP
is a potential orphan drug indication which would provide patent life
extension of 7 years post-approval.

 

The Board is confident that there is a route to market for P140 in lupus and
CIDP including further corporate collaborations.

 

Lupuzor™ and Avion Pharmaceuticals | Background

 

On 28 November 2019, ImmuPharma and Avion signed an exclusive Trademark,
License and Development Agreement for Lupuzor™/P140, with Avion agreeing to
fund a new international Phase 3 trial and commercialising Lupuzor™/P140 in
the US. The agreement also provides Avion an option on any other P140
indications. Since then, there have been two guidance meetings with the FDA on
the lupus program. At the first meeting the FDA requested ImmuPharma complete
a clinical PK study of P140. Following successful completion of the PK study
in 2022 the FDA guided on a new dosing regimen which has been built into a new
Phase 2/3 adaptive clinical trial design.

 

ImmuPharma and its US partner Avion co-developed and successfully completed a
clinical PK study of P140 which was announced on 13 April 2022. The study was
a Phase 1, open-label, single dose pharmacokinetic study of P140 after
subcutaneous and intravenous administration in healthy male volunteers.
Patients received a single subcutaneous injection of 200μg or 800μg P140 or
a single intravenous injection of 800μg P140. There was a clear time and
dose-related PK profile, which is detectable in the blood of human volunteers
and applicable for all potential clinical dosing regimens of P140. In-line
with all human dosing to date, P140 was safe and well tolerated across all
doses and in all subjects.

 

In the first half of 2022 ImmuPharma provided progress updates to the market
in respect to guidance meetings between the FDA and Avion. This concluded with
the FDA providing a detailed response in September 2022 to Avion with
significant guidance on next steps for the clinical programme. This included
advice on the dosing regime. In addition, the FDA also provided further
significant improvement guidance on the study protocol.

 

In February 2023, ImmuPharma confirmed that, with its partner Avion, they had
agreed on an adaptive Phase 2/3 study for Lupuzor™ in Systemic Lupus
Erythematosus ("SLE") patients. This is a one-protocol pivotal study which
allows exploration of a dose-range in the Phase 2 part of the study, followed
by seamless progression into the Phase 3 part of the study at the chosen dose.
The overall timelines for the Lupus clinical program are shorter as one avoids
the need for stopping and starting two independent trials, regulatory checks,
ethics approvals and site set-ups.  It is also expected to be less costly
overall. There is also an opportunity, through an interim analysis in the
Phase 3 part of the study, to stop the study earlier if an efficacy signal is
reached after a certain percentage of patients have been treated.

 

This new study design incorporates guidance from the FDA which advised
exploration of higher dose levels than have been used in the clinical program
to date. A clean safety profile has already been established at higher doses.

 

In April 2023, ImmuPharma confirmed that the FDA had a set date of 7 June 2023
for a type C meeting to consider the new Phase 2/3 study protocol, which
remains on track to commence in H2 20223.

 

CIDP / P140

 

For P140 in CIDP we announced in April 2023 that we had received confirmation
from the FDA for a pre- Investigational New Drug meeting date of 16 May
2023,  to consider a Phase 2/3 adaptive trial study protocol.

 

This will be the first pivotal stage clinical study of P140 in patients with
CIDP: a rare neurological disease with high medical need.

 

A new Investigational New Drug ("IND") submission is required, as this will be
the first time that P140 is to be studied in humans for the indication of
CIDP. An application for Orphan Drug status will be submitted following the
pre-IND meeting.

 

The CIDP market is expected to reach global sales of US$2.7bn by 2029 (source:
Data Bridge Market Research, Dec 2022).

 

Potential Distribution Agreement with Avion

As announced in November 2022, we have agreed to explore the opportunity of a
mutually beneficial route to allow ImmuPharma to introduce certain Avion
products into the European market. If this is successful, this would generate
top-line product sales revenue for the first time in ImmuPharma's history and
contribute net positive cash flow to the Company.

We in turn have identified an established European partner who could provide
the infrastructure to market and distribute the products.

Lupus ABC Consortium

 

The FDA's Center for Drug Evaluation and Research has partnered with the Lupus
Research Alliance (LRA) to launch the Lupus Accelerating Breakthroughs
Consortium (Lupus ABC), a first-of-its-kind public-private partnership focused
on addressing challenges impacting lupus clinical trial success.

 

Lupus ABC will convene people living with lupus, medical societies, industry,
academic clinical researchers and scientists, FDA, and other federal agencies
to address scientific hurdles that are beyond the capacity of any single
entity. By connecting those with lived experience with all parties involved in
lupus treatment research, CDER hopes to advance the development of urgently
needed treatments for lupus.

 

This can only be extremely good news for Lupus patients worldwide, including
ImmuPharma, our partners and our peers, in bringing new safe Lupus drugs to
the market, sooner rather than later.

 

 

 

Centre National de la Recherche Scientifique (CNRS)

 

ImmuPharma continues to have important collaboration arrangements with the
Centre National de la Recherche Scientifique ("CNRS"), the French National
Council for Scientific Research and the largest basic research organisation in
Europe. This is where Lupuzor™ /P140 platform was invented by Prof. Sylviane
Muller, Emeritus Research Director at the CNRS. Through this partnership, the
CNRS will be entitled to receive from ImmuPharma, low double-digit royalty
payments of funds received by ImmuPharma from Avion through the Licence and
Development Agreement and through further commercialisation deals for
territories outside of the US.

 

Pipeline Overview

 

There is a depth of scientific knowledge and innovation within the R&D
team in Bordeaux which is focusing on those product developments (see below)
which offer the highest probability of both scientific and commercial success.

 

Management continues to concentrate on identifying and concluding commercial
collaborations and licensing deals across the product portfolio.

 

Our therapeutic focus is on two core areas; Autoimmunity/Inflammation and
Anti-infection. We also look for valuable deals for non-core assets as
evidenced by a collaborative deal, signed in March 2023, with Orano on
ImmuPharma's peptide technology as a vector for cancer radiotherapy. The
initial collaboration is for 12 months and a small undisclosed upfront payment
was paid to ImmuPharma.

 

Autoimmunity & Inflammation

 

P140's mode of action is relevant to many autoimmune and inflammatory diseases
which provides a number of opportunities for ImmuPharma and its partners to
explore in the near future. The therapeutic potential of P140 goes beyond just
Lupus, with Chronic Inflammatory Demyelinating Polyneuropathy ("CIDP") being
the next step. P140's application across numerous disease states stems from
the research partnership between the Company and Prof. Sylviane Muller,
inventor of P140 and Emeritus Research Director CNRS, France. Key highlights
within the progression of the P140 platform are summarized below:

 

o  P140 - Lupuzor™  successfully completed PK study in 2022. A Phase 2/3
adaptive study is planned to commence in H2 2023. This is a one protocol
pivotal study which allows exploration of a dose range in the Phase 2 part of
the protocol.

 

o  P140 - CIDP a rare autoimmune disorder of peripheral nerves. CIDP is a
potential orphan drug indication which would provide patent life extension of
7 years post-approval. A Phase 2/3 adaptive trial is planned with IND/FDA
guidance and orphan drug designation application underway.

 

o  P140 - Second generation. Our pre-clinical team in Bordeaux, 'ImmuPharma
Biotech' has commenced work to develop a pharmacologically improved version of
P140, a second-generation product that aims to further strengthen the IP
position and provide therapies with different improved administration
modalities, yet still maintaining P140 as the active moiety.

 

o  P140 - Other indications. Further clinical applications based on further
preclinical investigation include asthma, Sjogrens syndrome, renal
inflammation in diabetes, periodontitis and gout.

 

Anti-Infection

 

The innovative peptide technology at ImmuPharma Biotech has been a huge
success and very recently has given rise to a number of novel development
programs, out of which we have identified two core programs, in pre-clinical
development; BioAMB and BioCin, which we believe have the best commercial
opportunity and speed to market. Despite the preclinical stage, these programs
are based on existing drugs that have been used for decades so the PK,
efficacy and safety of those drugs is well understood. They will also be
patent protected.

 

o  BioAMB, a novel peptide-based drug that offers a potential improvement on
the limiting side effects and poor administration regime of current
Amphotericin-B ("AMB") formulations. AMB is one of a last line of agents
against serious and life-threatening fungal infections caused by the
aspergillus family of fungi.

 

o  BioCin, a novel peptide-based drug based on an existing potent
antibacterial, vancomycin, used in high medical need cases and in many cases
the last line of defense. BioCin has the potential to offer improved safety
and administration benefits.

 

Interest in Incanthera Plc

 

As at 31 December 2022, ImmuPharma had a 12.97% interest in Oncology
specialist, Incanthera plc, which trades on Aquis Stock Exchange ("AQSE")
under the ticker (TIDM:INC).

 

ImmuPharma also has 7,272,740 warrants options in Incanthera at an exercise
price of 9.5p pence, being the price at which new shares were issued in the
Placing accompanying Incanthera's listing in 2020.

 

As announced in Incanthera's interim report in December 2022, the Company
continues to concentrate upon furthering discussions to capitalise on the
potential for various applications of its skincare portfolio for commercial
success.

 

As a major shareholder, ImmuPharma remains supportive of Incanthera.

 

Capital restructure

 

At the Annual General Meeting on 28 June 2022, the shareholders approved the
subdivision of the Company's ordinary share capital, whereby each existing
Ordinary Share with a nominal value of 10p was subdivided into 1 new Ordinary
Share of 1p and 1 Deferred Share of 9p. The Deferred Shares have no
significant rights attached to them and carry no right to vote or to
participate in distribution of surplus assets and are not admitted to trading
on the AIM market of the London Stock Exchange plc. The Deferred Shares
effectively carry no value.

 

Capital subscription

 

On 03  August 2022 ImmuPharma announced a subscription and placing to raise
c£1.1m  through the issue of 21,018,182 new ordinary shares of 1 pence each
in ImmuPharma at a price of 5p per ordinary share ("Issue Price"). This was
followed on 11 August 2022 by the completion of the associated Broker Option,
which raised £0.95m through the issue of 19,000,000 new ordinary shares of 1p
each in the Company at a price of 5p per ordinary share.

The monies raised included  a £1.0m subscription for 20,000,000 new ordinary
shares with Lanstead Capital Investors LP ("Lanstead"), at an Issue Price of 5
pence per share, together with a related Sharing Agreement.

The £1.0 million gross proceeds of the Lanstead subscription was followed by
the Sharing Agreement with Lanstead for 100% of these shares with a reference
price of 6.67p per share ("Benchmark Price"). The Sharing Agreement is for a
24 month period and the Company will receive 24 monthly settlements, as
measured against the Benchmark Price. The actual consideration is variable
depending upon ImmuPharma's share price and provides the opportunity for
ImmuPharma to benefit from a positive future share price performance or
conversely to receive less proceeds if there is negative future share price
performance.

The Company also agreed to issue Lanstead 1,400,000 ordinary shares in
connection with entering into the Sharing Agreement ("Value Payment Shares").

The Company also issued 200,000 new Ordinary Shares ("Fee Shares") at an issue
price of 5 pence per share to SPARK Advisory Partners Ltd in lieu of fees.

The Issue Price of 5 pence represented a 21.38% percent discount to the
closing mid-market price (of 6.36p) of the Ordinary Shares on 02 August 2022,
the latest business date prior to the Subscription and Placing.

Warrants

 

The Company agreed to issue Lanstead 30,000,000 warrants in return for
Lanstead foregoing the entitlement to increase the benchmark price in 2021
sharing agreement from 14.666p to 22p. The warrants are exercisable for 10
years at an exercise price of 5.5 pence.

The Company also issued 2,500,000 and 500,000 warrants to Stanford Capital
Partners "SCP" and SI Capital in lieu of fees. The warrants are exercisable
for 10 years at an exercise price of 5 pence.

During 2022, L1 Capital Global Opportunities Master Fund ("L1")  exercised
Options over 6,000,000 new ordinary shares of 1p each ("Ordinary Shares") at
an exercise price of 5p per share, for a consideration of £300,000.

Current Activities and Outlook

 

As a Board, we remain focused on bringing our two key late stage clinical
assets, Lupuzor™ and CIDP closer to the market. We now have a clinical
roadmap for Lupuzor™ and remain on track to commence the Phase 2/3 adaptive
trial in H2 2023, with potentially CIDP moving into clinical studies in
parallel. This illustrates the potential franchise we have within our P140
autoimmune platform.

We will also continue to concentrate on further commercial and partnering
opportunities. In conjunction with the above objectives, we continue to take
prudent measures on managing our cost base.

In closing, we would like to thank our shareholders for their support as well
as our staff, corporate and scientific advisers and our partners including
CNRS and Avion.

 

 

Tim McCarthy

Chairman & CEO

 

 

Financial Review

 

The financial results of the ImmuPharma Group in this report cover the year
ended 31 December 2022. The Group's principal activity is that of research and
development of novel drugs to treat serious medical conditions.

 

Income Statement and Statement of Comprehensive Income

 

The operating loss for the year ended 31 December 2022 was £3.0 million, down
from £6.6 million for the year ended 31 December 2021. The research and
development expenditure was £2.0 million, down from £3.7 million in 2021.
The decrease is a direct result of the corporate reorganisation in the prior
year.  Administrative expenses were £0.8 million (2021: £1.0 million). The
operating loss for the prior year included exceptional costs of £1.4 million
in respect of corporate reorganisation, including the departures of Board
members (including Dr Robert Zimmer and Dimitri Dimitriou) and respective
settlement agreements. No such costs have taken place during the year ended 31
December 2022.

 

Finance income has increased from £1k in 2021 to £29k in 2022. Finance costs
amounted to £1.5 million, down from £2.4 million in 2021, caused largely by
the comparative fair value calculations on the Lanstead derivative financial
asset and fair value loss on issue of warrants of £219k (2021: £nil). The
loss after tax for the year was £3.8 million, a decrease from £8.2 million
in 2021.

 

The amounts recognised directly in the Statement of Comprehensive Income
include the total fair value loss of £0.7 million (2021: fair value loss of
£1.0 million) which comprises the following components: fair value loss on
shares held in Incanthera plc of £520k (2021: fair value loss of £584k) and
fair value loss on Incanthera's warrants of £206k (2021: fair value loss of
£418k). Total comprehensive loss for the year was £4.5 million, a decrease
from £9.2 million in 2021.

 

Statement of Financial Position

 

The Group cash and cash equivalents at 31 December 2022 amounted to £0.7
million (2021: £1.6 million) with the decrease caused by the operating losses
including research and development expenditure related to PK study offset by
cash inflows from financing activities. Trade and other payables decreased to
£1.5 million (2021: £1.6 million) and was largely due to PK study related
expenditure. The total value of the financial asset equated to £0.7 million,
comprising of shares in Incanthera of £0.7 million (2021: £1.2 million) and
warrants in Incanthera of £0.001 million (2021: £0.2 million). At 31
December 2022 the Lanstead derivative financial asset amounted to £0.3
million (2021: £0.9 million). The decrease was a result of the fair value
calculation performed at year end, reflecting the decrease in ImmuPharma's
share price.

 

Results

 

The Group recorded a loss for the year of £3.8 million (2021: £8.2 million).
Basic and diluted loss per share was 1.26p (2021: 3.25p). In accordance with
the Group's loss making position, no dividend is proposed.

 

Capital restructure

 

At the Annual General Meeting on 28 June 2022, the shareholders approved the
subdivision of the Company's ordinary share capital, whereby each existing
Ordinary Share with a nominal value of 10p was subdivided into 1 new Ordinary
Share of 1p and 1 Deferred Share of 9p. The Deferred Shares have no
significant rights attached to them and carry no right to vote or to
participate in distribution of surplus assets and are not admitted to trading
on the AIM market of the London Stock Exchange plc. The Deferred Shares
effectively carry no value.

 

Total Voting Rights & Warrants

 

The Company had a total of 618,388,048 ordinary shares in issue at 31 December
2022.  The Company's issued share capital now comprises 333,403,115 Ordinary
Shares with one voting right each and 284,984,933 deferred shares with no
rights to vote. Total warrants outstanding equal: 151,450,908.

 

Treasury Policy

 

The policy continues to be that surplus funds of the Group are held in
interest-bearing bank accounts on short or medium maturities, until
commitments to future expenditure are made, when adequate funds are released
to enable future expenditure to be incurred. The Group's Treasury Policy and
controls are straightforward and approved by the Board.

 

Financial Strategy

 

The overall strategy is to maintain a tight control over cash resources whilst
enabling continued progress of the Company's development assets.

 

 

 

 

On behalf of the Board

 

 

 

 

Tim McCarthy

Director

 

CONSOLIDATED INCOME STATEMENT

FOR THE YEAR ENDED 31 DECEMBER 2022

 

                                               Year ended           Year ended

                                       Notes   31 December 2022     31 December 2021
                                               £                    £
 Continuing operations
 Revenue                                       -                    118,350
 Research and development expenses             (2,022,507)          (3,650,400)
 Exceptional items                             -                    (1,427,084)
 Administrative expenses                       (846,571)            (1,011,398)
 Share based payment expense                   (159,874)            (616,423)

 Operating loss                                (3,028,952)          (6,586,955)

 Finance costs                                 (1,455,966)          (2,354,872)
 Finance income                                28,585               1,107

 Loss before taxation                          (4,456,333)          (8,940,720)

 Tax                                           648,902              766,815

 Loss for the year                             (3,807,431)          (8,173,905)

 Attributable to:
 Equity holders of the parent company          (3,807,431)          (8,173,905)

 Loss per ordinary share

 Basic and diluted                     2       (1.26)p              (3.25)p

 

 

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE YEAR ENDED 31 DECEMBER 2022

 

 

                                                                                                 Year                                Year

                                                                                                  ended 31 December                   ended 31 December

                                                                                                 2022                                 2021
                                                                                                 £                             £

 Loss for the financial period                                                                   (3,807,431)                   (8,173,905)

 Other comprehensive income
 Items that will not be reclassified subsequently to profit or loss:

 Fair value loss on investment                                                                   (519,977)                     (584,355)
 Fair value loss on warrants owned                                                               (206,279)                     (418,068)

 Total items that will not be reclassified subsequently to profit or loss                        (726,256)                     (1,002,423)

 Items that may be reclassified subsequently to profit or loss:

 Exchange differences on translation of foreign operations                                       79,104                        (36,177)

 Total items that may be reclassified subsequently to profit or loss                             79,104                        (36,177)

 Other comprehensive loss for the period                                                         (647,152)                     (1,038,600)

 Total comprehensive loss for the period                                                         (4,454,583)                   (9,212,505)

 

 

 

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2022

                                         31 December 2022    31 December 2021
                                         £                   £

 Non-current assets
 Intangible assets                       473,892             477,553
 Property, plant and equipment           389,716             352,996
 Derivative financial asset              82,563              405,489
 Financial assets                        689,579             1,415,835

 Total non-current assets                1,635,750           2,651,873

 Current assets
 Trade and other receivables             723,583             427,199
 Derivative financial asset              252,258             508,167
 Cash and cash equivalents               667,813             1,649,374
 Current tax asset                       695,297             761,188

 Total current assets                    2,338,951           3,345,928

 Current liabilities
 Financial liabilities - borrowings      (111)               (700)
 Trade and other payables                (1,451,213)         (1,583,604)
 Convertible loan notes                  -                   -

 Total current liabilities               (1,451,324)         (1,584,304)

 Net current assets                      887,627             1,761,624

 Net assets                              2,523,377           4,413,497

 EQUITY
 Ordinary shares                         28,982,676          28,498,494
 Share premium                           28,788,377          27,237,329
 Merger reserve                          106,148             106,148
 Other reserves                          5,761,496           5,153,159
 Retained earnings                       (61,115,320)        (56,581,633)

 Total equity                            2,523,377           4,413,497

The financial statements were approved by the Board of Directors and
authorised for issue on 10 May 2023

They were signed on its behalf by:

 

 

Tim
McCarthy
Tim Franklin

Director
Director

 

                     CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

                     FOR THE YEAR ENDED 31 DECEMBER 2022

                                                                                                                                                                                                               Other reserves - Share based payment reserve        Other reserves - Convertible option reserve

                                                                                                                         Other reserves - Acquisition reserve       Other reserves - Translation reserve                                                                                                                     Other reserves - Warrant reserve

                                                            Share capital       Share premium       Merger reserve                                                                                                                                                                                                                                                         Retained earnings

                                                                                                                                                                                                                                                                                                                                                                                                                Total equity
                                                            £                   £                   £                    £                                          £                                          £                                                                                     £                                          £                                      £                        £

 At 1 January 2021                    25,022,130                                27,237,329          106,148              (3,541,203)                                (1,308,480)                                8,073,596                                                                             31,623                                     -                                      (45,966,347)             9,654,796

 Loss for the financial year          -                                         -                   -                    -                                          -                                          -                                                                                     -                                          -                                      (8,173,905)              (8,173,905)
 Exchange differences on translation

 of foreign operations                -                                         -                   -                    -                                          (36,177)                                   -                                                                                     -                                          -                                      -                        (36,177)
 Transactions with owners:

 Share based payments                 -                                         -                   -                    -                                          -                                          616,423                                                                               -                                          -                                      -                        616,423
 New issue of equity capital                                3,476,364           322,727             -                    -                                          -                                          -                                                                                     -                                          -                                      (1,349,000)              2,450,091
 Costs of new issue of equity capital                       -                   (322,727)           -                    -                                          -                                          -                                                                                     -                                          -                                      (121,581)                (444,308)
 Fair value loss on investments                             -                   -                   -                    -                                          -                                          -                                                                                     -                                          -                                      (584,355)                (584,355)
 Fair value loss on share warrants                          -                   -                   -                    -                                          -                                          -                                                                                     -                                          -                                      (418,068)                (418,068)
 Settlement of convertible loans reserve                    -                   -                   -                    -                                          -                                          -                                                                                     (31,623)                                   -                                      31,623                   -
 Issue of warrants                                          -                   -                   -                    -                                          -                                          -                                                                                     -                                          1,349,000                              -                        1,349,000

 At 31 December 2021                                        28,498,494          27,237,329          106,148              (3,541,203)                                (1,344,657)                                8,690,019                                                                             -                                          1,349,000                              (56,581,633)             4,413,497

 Loss for the financial year                                -                   -                   -                    -                                          -                                          -                                                                                     -                                          -                                      (3,807,431)              (3,807,431)
 Exchange differences on translation

 of foreign operations                                      -                   -                   -                    -                                          79,104                                     -                                                                                     -                                          -                                      -                        79,104
 Transactions with owners:

 Share based payments                                       -                   -                   -                    -                                          -                                          159,874                                                                               -                                          -                                      -                        159,874
 New issue of equity capital                                484,182             1,866,727           -                    -                                          -                                          -                                                                                     -                                          -                                      -                        2,350,909
 Costs of new issue of equity capital                       -                   (165,679)           -                    -                                          -                                          -                                                                                     -                                          -                                      -                        (165,679)
 Fair value loss on investments                             -                   -                   -                    -                                          -                                          -                                                                                     -                                          -                                      (519,977)                (519,977)
 Fair value loss on share warrants                          -                   -                   -                    -                                          -                                          -                                                                                     -                                          -                                      (206,279)                (206,279)
 Issue of warrants                                          -                   (150,000)           -                    -                                          -                                          -                                                                                     -                                          369,359                                -                        219,359

 At 31 December 2022                                        28,982,676          28,788,377          106,148              (3,541,203)                                (1,265,553)                                8,849,893                                                                             -                                          1,718,359                              (61,115,320)             2,523,377

 Equity holders of the parent company                       28,982,676          28,788,377          106,148              (3,541,203)                                (1,265,553)                                8,849,893                                                                             -                                          1,718,359                              (61,115,320)             2,523,377

CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE YEAR ENDED 31 DECEMBER 2022

 

                                                                                                       Year ended             Year ended

                                                                                                       31 December 2022       31 December

                                                                                                                              2021
                                                                                                       £                      £

 Cash flows from operating activities
 Cash used in operations                                                                               (3,224,906)            (5,222,446)
 Tax received                                                                                          879,877                392,217
 Interest paid                                                                                         (2,036)                (2,943)

 Net cash used in operating activities                                                                 (2,347,065)            (4,833,172)

 Investing activities
 Purchase of property, plant and equipment                                                             (106,009)              (50,934)
 Interest received                                                                                     28,585                 651

 Net cash used in investing activities                                                                 (77,424)               (50,283)

 Financing activities
 Decrease in bank overdraft                                                                            -                      (211)
 Loan repayments                                                                                       -                      (6,028)
 Settlements from Sharing Agreement                                                                    362,500                328,495
 Gross proceeds from issue of new share capital                                                        2,350,909              3,550,000
 Share capital issue costs                                                                             (165,679)              (132,350)
 Funds deferred per Sharing Agreement                                                                  (1,000,000)            (2,200,000)
 Interest paid on convertible loan notes                                                               -                      (121,120)
 Convertible loan notes repaid                                                                         -                      (716,739)

 Net cash generated from financing activities                                                          1,547,730              702,047

 Net increase/(decrease) in cash and cash equivalents                                                  (876,759)              (4,181,408)

 Cash and cash equivalents at beginning of year                                                        1,649,374              5,862,057

 Effects of exchange rates on cash and cash equivalents                                                (104,802)              (31,275)

 Cash and cash equivalents at end of year (excluding overdraft)                                        667,813                1,649,374

 

 

 1    BASIS OF PREPARATION

      The financial information set out in this announcement does not comprise the
      Group's statutory accounts as defined in section 434 of the Companies Act 2006
      for the year ended 31 December 2022 or 31 December 2021.

      The financial information has been extracted from the statutory accounts for
      the years ended 31 December 2022 and 31 December 2021. The auditors reported
      on those accounts; their reports were unqualified and did not contain a
      statement under either Section 498(2) or Section 498(3) of the Companies Act
      2006 in respect of the years ended 31 December 2022 and 31 December 2021. For
      the year ended 31 December 2022 and 31 December 2021 it did include an
      emphasis of matter paragraph relating to the carrying value of Parent
      Company's investment in subsidiaries and receivables due from group
      undertakings, and a reference to which the auditor drew attention by way of
      emphasis without qualifying their report in respect of going concern.

      The Group's statutory accounts for the year ended 31 December 2021 have been
      delivered to the Registrar of Companies, whereas those for the year ended 31
      December 2022 will be delivered to the Registrar of Companies following the
      Company's Annual General Meeting.

      The accounting policies are consistent with those applied in the preparation
      of the statutory accounts for the year ended 31 December 2021 and interim
      results for the period ended 30 June 2022, which have been prepared in
      accordance with International Financial Reporting Standards ('IFRS').

      The financial information is for the year ended 31 December 2022 and the
      comparatives are for the year ended 31 December 2021.

      The Group's statutory accounts incorporate the financial statements of
      ImmuPharma plc and other entities controlled by the company ("the
      subsidiaries"). The control principle in IFRS 10 sets out the following three
      elements of control: power over the investee; exposure, or rights, to variable
      returns from involvement with the investee; and. the ability to use power over
      the investee to affect the amount of those returns. The financial statements
      of these other entities cease to be included in the Group financial statements
      from the date that control ceases.

 

 

 2. LOSS PER SHARE

 - Group                                                                        Year ended 31 December 2022       Year ended

                                                                                                                  31 December 2021
                                                                                £                                 £
 Loss
 Loss for the purposes of basic loss per share being net loss after tax
 attributable to equity shareholders

                                                                                (3,807,431)                       (8,173,905)

 Number of shares
 Weighted average number of ordinary shares for the purposes of basic earnings
 per share

                                                                                302,912,903                       251,164,361

 Basic loss per share                                                           (1.26)p                           (3.25)p

 Diluted loss per share                                                         (1.26)p                           (3.25)p

 There is no difference between basic loss per share and diluted loss per share
 as the share options and warrants are anti-dilutive.

 

 

 3. CASH USED IN OPERATIONS
                   Group                                                                     Group                        Company                   Company

                   31 December 2022                                                          31 December 2021             31 December 2022          31 December 2021
                                     £                                                                  £                 £                         £
 Operating loss                      (3,028,952)                                                        (6,586,955)       (1,567,079)               (4,260,273)
 Depreciation and amortisation                                                 117,563                  114,119           4,312                     4,459
 Profit on sale of fixed assets                                                939                      -                 939                       -
 Share-based payments                                                          159,874                  616,423           129,799                   568,157
 (Increase)/decrease in trade and other receivables                   (296,384)                         (265,201)

                                                                                                                          37,900                    (22,880)
 (Decrease)/increase in trade and other payables       (132,392)                                        896,798

                                                                                                                          (505,554)                 483,767
 (Gain)/loss on foreign exchange                                               (45,554)                 2,370

                                                                                                                          -                         (7,277)

 Cash used in operations                               (3,224,906)                                      (5,222,446)       (1,899,683)               (3,234,047)

4. ANNUAL REPORT

 

The annual report for the year ended 31 December 2022 will be posted to
shareholders shortly, and will be made available on the Company's website
www.immupharma.co.uk (http://www.immupharma.co.uk/) .

 

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.   END  FR KZGMKLGLGFZM

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